Active — Not RecruitingNot Applicable

Pelvic Fixation and Fusion During Multilevel Spinal Surgery

United States200 participantsStarted 2023-06-05

Plain-language summary

PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥ 18 years of age at screening.
✓. Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite
✓. Patient is willing and able to provide written informed consent

Exclusion criteria

✕. Any known anatomic issues or permanent implants already in the pelvis that could interfere with placement of the study device(s)
✕. Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation
✕. Known allergy to titanium or titanium alloys
✕. Current local or systemic infection that raises the risk of surgery
✕. Currently pregnant or planning pregnancy in the next 2 years
✕. Known or suspected active drug or alcohol abuse, including opioids
✕. Patient is a prisoner or ward of the state
✕. Patient is enrolled in an investigational clinical trial related to the spine

What they're measuring

Postoperative incidence of serious adverse events probably or definitely related to GRANITE

Timeframe: 2 years

Postoperative incidence of SI joint pain in subject without SI joint pain at baseline

Timeframe: 2 years

Postoperative incidence of L5-S1 pseudoarthrosis

Timeframe: 2 years

Postoperative incidence of pelvic construct failure

Timeframe: 2 years

Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)

Timeframe: 2 years

Radiographic

Timeframe: 12 month and 24 months

Change in Quality of Life PROs

Timeframe: 6 month, 12 month and 24 months

Trial details

NCT IDNCT05640908

SponsorSI-BONE, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-11

View on ClinicalTrials.gov More Spinal Fusion trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥ 18 years of age at screening.
✓. Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite
✓. Patient is willing and able to provide written informed consent

Exclusion criteria

✕. Any known anatomic issues or permanent implants already in the pelvis that could interfere with placement of the study device(s)
✕. Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation
✕. Known allergy to titanium or titanium alloys
✕. Current local or systemic infection that raises the risk of surgery
✕. Currently pregnant or planning pregnancy in the next 2 years
✕. Known or suspected active drug or alcohol abuse, including opioids
✕. Patient is a prisoner or ward of the state
✕. Patient is enrolled in an investigational clinical trial related to the spine

What they're measuring

Postoperative incidence of serious adverse events probably or definitely related to GRANITE

Timeframe: 2 years

Postoperative incidence of SI joint pain in subject without SI joint pain at baseline

Timeframe: 2 years

Postoperative incidence of L5-S1 pseudoarthrosis

Timeframe: 2 years

Postoperative incidence of pelvic construct failure

Timeframe: 2 years

Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)

Timeframe: 2 years

Radiographic

Timeframe: 12 month and 24 months

Change in Quality of Life PROs

Timeframe: 6 month, 12 month and 24 months